NCT06513273Recruiting
Observational Study on the Outcome of AML Patients Treated With New Drugs in Real-life (BoxTrial)
Observational GIMEMA Study on the Outcome of Acute Myeloid Leukemia (AML) Patients Treated With New Drugs in Real-life
Source: ClinicalTrials.gov · Last updated 13 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This multicenter, prospective and retrospective observational study aims to evaluate the use and efficacy of new drugs or their combinations in real-life in a population of adult AML patients.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 397 (estimated)
- First submitted
- 16 Jul 2024
- Start date
- 11 Jul 2025
- Primary completion date
- Dec 2029
- Lead sponsor
- Gruppo Italiano Malattie EMatologiche dell'Adulto
- Diseases
- Acute myeloid leukemia
- NCT number
- NCT06513273
What you commit to
- Study type: Observational
- Planned participants: 397
- From 11 Jul 2025 to the primary completion date, Dec 2029
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Patients included in interventional clinical trials.
Who the study is looking for
- Aged 18 years or older
- AML diagnosis according to the ELN guidelines, excluding M3
- Signed Informed consent, if applicable
- Treatment initiation with novel drugs in monotherapy or combination, in accordance with the AIFA authorizations, from the AIFA registration up to 31.12.2027 with particular attention to:
- patients affected by FLT3-mutated AML treated with gilteritinib.
- patients affected by IDH-mutated AML treated with IDH inhibitors.
- patients affected by AML in maintenance therapy with oral azacytidine.
- patients affected by AML treated with glasdegib.
- patients affected by AML treated with gemtuzumab ozogamicin.
- other novel drugs or combination for the treatment of AML approved during the study period.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ematologia Ente Ecclesiastico Casa Sollievo Della Sofferenza Coordinator of this site? Confirm its status | San Giovanni Rotondo | Italy | Recruiting |
| UOC Ematologia AOU di SASSARI Coordinator of this site? Confirm its status | Sassari | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.